Aortic catheter and methods for inducing cardioplegic arrest and for selective aortic perfusion

ABSTRACT

The present invention provides an aortic catheter having an upstream occlusion member positioned in the ascending aorta between the coronary arteries and the brachiocephalic artery and a downstream anchoring member positioned in the descending aorta, downstream of the aortic arch. The upstream occlusion member may be an inflatable balloon or a selectively deployable external catheter valve. The downstream anchoring member may be a larger inflatable balloon or other anchoring structure that provides sufficient friction to prevent migration of the balloon catheter in the upstream or downstream direction. In addition, an arch perfusion lumen, a corporeal perfusion lumen and a cardioplegia lumen are provided for performing selective perfusion and cardioplegic arrest.

FIELD OF THE INVENTION

This application claims the benefit of U.S. Provisional PatentApplication serial No. 60/067,945 filed on Dec. 08, 1997, now abandonedthe specification of which is hereby incorporated by reference in itsentirety.

The present invention relates to an aortic catheter for inducingcardioplegic arrest and for segmenting and selectively perfusing theaorta during cardiopulmonary bypass.

BACKGROUND OF THE INVENTION

Recent advances in the field of minimally invasive cardiac surgery haveincluded the development of aortic catheters and methods for inducingcardioplegic arrest without the necessity of opening the patient's chestwith a sternotomy or other major thoracotomy. For example, U.S. Pat. No.Re 35,352 to Peters describes a single balloon catheter for occluding apatient's ascending aorta and a method for inducing cardioplegic arrest.A perfusion lumen or a contralateral arterial cannula is provided forsupplying oxygenated blood during cardiopulmonary bypass. U.S. Pat. No.5,584,803 to Stevens et al. describes a single balloon catheter forinducing cardioplegic arrest and a system for providing cardiopulmonarysupport during closed chest cardiac surgery. A coaxial arterial cannulais provided for supplying oxygenated blood during cardiopulmonarybypass. The occlusion balloon of these catheters must be very carefullyplaced in the ascending aorta between the coronary arteries and thebrachiocephalic artery, therefore the position of the catheter must becontinuously monitored to avoid complications. In clinical use, thesesingle balloon catheters have shown a tendency to migrate in thedirection of the pressure gradient within the aorta. That is to saythat, during infusion of cardioplegia, the balloon catheter will tend tomigrate downstream due to the higher pressure on the upstream side ofthe balloon and, when the CPB pump is on, the balloon catheter with tendto migrate upstream into the aortic root due to the higher pressure onthe downstream side of the balloon. This migration can be problematic ifthe balloon migrates far enough to occlude the brachiocephalic artery onthe downstream side or the coronary arteries on the upstream side. PCTpatent application WO 97/21462 by Fan et al. attempts to overcome thisproblem with a balloon catheter having high friction areas on the outersurface of the balloon. A problem with this single balloon approach isthat a relatively large balloon is needed to create enough friction toavoid migration of the inflated balloon. The larger the balloon is, themore carefully it must be placed in the ascending aorta to avoidoccluding the coronary arteries or the brachiocephalic artery and theless margin of error there is should any balloon migration occur.

U.S. Pat. No 5,312,344 to Grinfeld et al. describes an arterialperfusion cannula having two closely spaced balloons positioned in theascending aorta. However, this patent does not provide any guidance onhow to avoid migration or inadvertent occlusion of the coronary arteriesor the brachiocephalic artery. It would be desirable to provide anaortic occlusion catheter for inducing cardioplegic arrest thatminimizes the likelihood of migration of the balloon or occluding memberin the ascending aorta.

Another important development in the area of aortic balloon catheters isthe concept of selective aortic perfusion. U.S. Pat. Nos. 5,308,320,5,383,854 and 5,820,593 by Peter Safar, S. William Stezoski and MiroslavKlain describe a double balloon catheter for segmenting a patient'saorta for selective perfusion of different organ systems within thebody. Other U.S. patents which address the concept of selective aorticperfusion include U.S. Pat. Nos.; 5,738,649, 5,833,671 and 5,827,237 byJohn A. Macoviak; and Michael Ross and commonly owned, copending patentapplications Ser. No.; 08/909,293 filed Aug. 11, 1997; and Ser. No.08/909,380 filed Nov. 8, 1997, by Safar et al.; and Ser. No. 08/665,635,filed Jun. 18, 1996 by John A. Macoviak; and Michael Ross. These patentapplications and all other patents referred to herein are herebyincorporated by reference in their entirety. Selective perfusion can beused to prioritize the flow of oxygenated blood or other protectivefluids to the various organ systems, therefore achieving optimalpreservation of all organ systems within the body. It would be desirableto include this feature of selective perfusion in an aortic occlusioncatheter for inducing cardioplegic arrest.

SUMMARY OF THE INVENTION

Accordingly, the present invention provides an aortic catheter having anupstream occlusion member positioned in the ascending aorta between thecoronary arteries and the brachiocephalic artery and a downstreamanchoring member positioned in the descending aorta, downstream of theaortic arch. The upstream occlusion member may be an inflatable balloonor a selectively deployable external catheter valve. Preferably, theupstream occlusion member is narrow enough in construction that it iseasily placed between the coronary arteries and the brachiocephalicartery without any danger of inadvertently occluding either. Thedownstream anchoring member may be a larger inflatable balloon or otheranchoring structure that provides sufficient friction to preventmigration of the balloon catheter in the upstream or downstreamdirection. Preferably, the upstream occlusion member and the downstreamanchoring member are mounted on an elongated catheter shaft, whichincludes lumens for inflating or otherwise actuating the occlusionmember and the anchoring member and a lumen or lumens for perfusion ofthe aorta with oxygenated blood or other fluids. The catheter may beconfigured for retrograde deployment via a peripheral artery, such asthe femoral artery, or it may be configured for antegrade deployment viaan aortotomy incision or direct puncture in the ascending aorta.

A first embodiment of the aortic catheter of the present invention isdescribed, which is configured for retrograde deployment via aperipheral artery, such as the femoral artery. The aortic catheter hasan elongated catheter shaft having a proximal end and a distal end. Anupstream occlusion member, in the form of an inflatable balloon, ismounted on the catheter shaft near the distal end of the catheter shaftso that it is positioned in the ascending aorta when deployed. A largerinflatable balloon, which serves as a downstream anchoring member, ismounted at a position proximal to the upstream occlusion member so thatit is positioned in the descending aorta when deployed. A corporealperfusion lumen extends through the catheter shaft from the proximal endto one or more corporeal perfusion ports on the exterior of the cathetershaft proximal of the downstream anchoring member. An arch perfusionlumen extends through the catheter shaft from the proximal end to one ormore arch perfusion ports on the exterior of the catheter shaft betweenthe upstream occlusion member and the downstream anchoring member. Anarch pressure lumen extends through the catheter shaft from the proximalend to an arch pressure port located between the upstream occlusionmember and the downstream anchoring member to monitor pressure in theaortic arch. A common balloon inflation lumen extends through thecatheter shaft from the proximal end to balloon inflation ports withinthe upstream occlusion member and the downstream anchoring member. Aroot pressure lumen extends through the catheter shaft from the proximalend to a root pressure port near the distal end of the catheter shaft tomonitor pressure in the aortic root. A guide wire and cardioplegia lumenextends from the proximal end of the catheter shaft to the distal end,distal to the upstream occlusion member.

A second embodiment of the aortic catheter is described, which is alsoconfigured for retrograde deployment via a peripheral artery, such asthe femoral artery. The aortic catheter has an elongated catheter shafthaving a proximal end and a distal end. An upstream occlusion member, inthe form of an inflatable balloon, is mounted on the catheter shaft nearthe distal end of the catheter shaft so that it is positioned in theascending aorta when deployed. A larger inflatable balloon, which servesas a downstream anchoring member, is mounted at a position proximal tothe upstream occlusion member so that it is positioned in the descendingaorta when deployed. An arch perfusion lumen extends through thecatheter shaft from the proximal end to one or more arch perfusion portson the exterior of the catheter shaft between the upstream occlusionmember and the downstream anchoring member. An arch pressure lumenextends through the catheter shaft from the proximal end to an archpressure port located between the upstream occlusion member and thedownstream anchoring member to monitor pressure in the aortic arch. Acommon balloon inflation lumen extends through the catheter shaft fromthe proximal end to balloon inflation ports within the upstreamocclusion member and the downstream anchoring member. A root pressurelumen extends through the catheter shaft from the proximal end to a rootpressure port near the distal end of the catheter shaft to monitorpressure in the aortic root. A guide wire and cardioplegia lumen extendsfrom the proximal end of the catheter shaft to the distal end, distal tothe upstream occlusion member. A separate contralateral or coaxialarterial cannula would be used with this embodiment of the aorticcatheter to supply oxygenated blood to the corporeal circulation.

A third embodiment of the aortic catheter of the present invention isdescribed, which is configured for antegrade deployment via an aortotomyor direct aortic puncture. The aortic catheter has an elongated cathetershaft having a proximal end and a distal end. Because the catheter isconfigured for antegrade deployment, the proximal and distal positionsof many of the features of the catheter are reversed with respect to theretrograde embodiments previously described. A downstream anchoringmember, in the form of a large inflatable balloon, is mounted on thecatheter shaft near the distal end of the catheter shaft so that it ispositioned in the descending aorta when deployed. An upstream occlusionmember, in the form of an inflatable balloon, is mounted at a positionproximal to the downstream anchoring member so that it is positioned inthe ascending aorta when deployed. An arch perfusion lumen extendsthrough the catheter shaft from the proximal end to one or more archperfusion ports on the exterior of the catheter shaft between theupstream occlusion member and the downstream anchoring member. An archpressure lumen extends through the catheter shaft from the proximal endto an arch pressure port located between the upstream occlusion memberand the downstream anchoring member to monitor pressure in the aorticarch. A common balloon inflation lumen extends through the cathetershaft from the proximal end to balloon inflation ports within theupstream occlusion member and the downstream anchoring member. A guidewire and corporeal perfusion lumen extends from the proximal end of thecatheter shaft to the distal end, distal to the downstream anchoringmember. A separate cardioplegia needle or catheter would be used withthis embodiment of the aortic catheter to infuse cardioplegia fluid intothe aortic root upstream of the upstream occlusion member.

A fourth embodiment of the aortic catheter, configured for retrogradedeployment, is described wherein the upstream occlusion member is in theform of a narrow, disk shaped balloon. A fifth embodiment of the aorticcatheter, configured for antegrade deployment, is described wherein theupstream occlusion member is in the form of a narrow, disk shapedballoon.

A sixth embodiment of the aortic catheter, configured for retrogradedeployment, is described wherein the upstream occlusion member is in theform of a selectively deployable peripheral flow external cathetervalve. A seventh embodiment of the aortic catheter, also configured forretrograde deployment, is described wherein the upstream occlusionmember is in the form of a selectively deployable central flow externalcatheter valve. An eighth embodiment of the aortic catheter, configuredfor retrograde deployment, is described wherein the downstream anchoringmember is in the form of two inflatable balloons.

Methods according to the present invention are described using theaortic catheter for occluding the ascending aorta and for inducingcardioplegic arrest, for supporting the patient's circulation oncardiopulmonary bypass, for partitioning the patient's aorta and forperforming selective aortic perfusion.

BRIEF DESCRIPTION OF THE DRAWINGS

FIG. 1 shows a side view of a first embodiment of the aortic catheter ofthe present invention configured for retrograde deployment via aperipheral artery access, such as the femoral artery.

FIG. 2 is a magnified lateral cross section of the aortic catheter ofFIG. 1 taken along line 2--2 in FIG. 1.

FIG. 3 is a magnified lateral cross section of the aortic catheter ofFIG. 1 taken along line 3--3 in FIG. 1.

FIG. 4 is a magnified distal view of the aortic catheter of FIG. 1 takenalong line 4--4 in FIG. 1.

FIG. 5 is a full scale drawing of the lateral cross section taken alongline 2--2 in FIG. 1 showing the actual size of a catheter with a 10.5French (3.5 mm) outer diameter.

FIG. 6 is a full scale drawing of the lateral cross section taken alongline 3--3 in FIG. 1 showing the actual size of a catheter with a 10.5French (3.5 mm) outer diameter.

FIG. 7 is a full scale drawing of the lateral cross section taken alongline 2--2 in FIG. 1 showing the actual size of a catheter with a 12French (4.0 mm) outer diameter.

FIG. 8 is a full scale drawing of the lateral cross section taken alongline 3--3 in FIG. 1 showing the actual size of a catheter with a 12French (4.0 mm) outer diameter.

FIG. 9 shows a side view of a second embodiment of the aortic catheterof the present invention configured for retrograde deployment via aperipheral artery access, such as the femoral artery.

FIG. 10 is a magnified lateral cross section of the aortic catheter ofFIG. 9 taken along line 10--10 in FIG 9.

FIG. 11 is a magnified lateral distal view of the aortic catheter ofFIG. 9 taken along line 11--11 in FIG. 9.

FIG. 12 is a full scale drawing of the lateral cross section taken alongline 10--10 in FIG. 9 showing the actual size of a catheter with a 10.5French (3.5 mm) outer diameter.

FIG. 13 is a full scale drawing of the lateral cross section taken alongline 11--11 in FIG. 9 showing the actual size of a catheter with a 12French (4.0 mm) outer diameter.

FIG. 14 shows a side view of an aortic catheter according to the presentinvention with a catheter shaft configured for retrograde deployment viafemoral artery access.

FIG. 15 shows a side view of the aortic catheter according to thepresent invention with a catheter shaft configured for retrogradedeployment via femoral artery access.

FIG. 16 shows a side view of a third embodiment of the aortic catheteraccording to the present invention with a catheter shaft configured forantegrade deployment via an aortotomy incision in the ascending aorta.

FIG. 17 is a magnified lateral cross section of the aortic catheter ofFIG. 16 taken along line 17--17 in FIG. 16.

FIG. 18 is a magnified lateral cross section of the aortic catheter ofFIG. 16 taken along line 18--18 in FIG. 16.

FIG. 19 is a magnified lateral cross section of the aortic catheter ofFIG. 16 taken along line 19--19 in FIG. 16.

FIG. 20 is a full scale drawing of the lateral cross section taken alongline 17--17 in FIG. 16 showing the actual size of a catheter with a 10.5French (3.5 mm) outer diameter.

FIG. 21 is a full scale drawing of the lateral cross section taken alongline 18--18 in FIG. 16 showing the actual size of a catheter with a 10.5French (3.5 mm) outer diameter.

FIG. 22 is a full scale drawing of the lateral cross section taken alongline 17--17 in FIG. 16 showing the actual size of a catheter with a 12French (4.0 mm) outer diameter.

FIG. 23 is a full scale drawing of the lateral cross section taken alongline 18--18 in FIG. 16 showing the actual size of a catheter with a 12French (4.0 mm) outer diameter.

FIG. 24 shows a side view of an aortic catheter according to the presentinvention with a catheter shaft configured for antegrade deployment viaan aortotomy incision in the ascending aorta.

FIG. 25 is a schematic diagram of an aortic catheter according to thepresent invention, deployed within a patient's aorta via an aortotomyincision in the ascending aorta.

FIG. 26 is a schematic diagram showing a fourth embodiment of the aorticcatheter, having an upstream occlusion member in the form of a narrow,disk-shaped balloon, deployed within a patient's aorta via femoralartery access.

FIG. 27 is a schematic diagram showing a fifth embodiment of the aorticcatheter, having an upstream occlusion member in the form of a narrow,disk-shaped balloon, deployed within a patient's aorta via an aortotomyincision in the ascending aorta.

FIG. 28 is a schematic diagram showing a sixth embodiment of the aorticcatheter, having an upstream occlusion member in the form of aselectively deployable peripheral flow external catheter valve, deployedwithin a patient's aorta via femoral artery access.

FIG. 29 is a schematic diagram showing a seventh embodiment of theaortic catheter, having an upstream occlusion member in the form of aselectively deployable central flow external catheter valve deployedwithin a patient's aorta via femoral artery access.

FIG. 30 is a schematic diagram showing an eighth embodiment of theaortic catheter, having a downstream anchoring member in the form of twoinflatable balloons, deployed within a patient's aorta via femoralartery access.

DETAILED DESCRIPTION OF THE INVENTION

FIGS. 1 through 8 illustrate the shaft portion of a first embodiment ofthe aortic catheter 100 of the present invention, which is configuredfor retrograde deployment via a peripheral artery, such as the femoralartery. FIG. 1 is a side view of the shaft portion of the aorticcatheter 100. FIG. 2 is a magnified lateral cross section of the aorticcatheter 100 taken along line 2--2 in FIG. 1. FIG. 3 is a magnifiedlateral cross section of the aortic catheter 100 taken along line 3--3in FIG. 1. FIG. 4 is a magnified distal end view of the aortic catheter100 taken along line 4--4. The aortic catheter 100 has an elongatedcatheter shaft 102 having a proximal end 104 and a distal end 106. Theelongated catheter shaft 102 should have an overall length sufficient toreach from an arterial insertion point to the patient's ascending aorta.For femoral artery deployment in adult human patients, the elongatedcatheter shaft 102 preferably has an overall length from approximately60 to 120 cm, more preferably 70 to 90 cm. The elongated catheter shaft102 has a proximal portion 1 and a distal portion 2, which are joinedtogether end-to-end, as shown in FIG. 1.

As shown in FIG. 2, which is a magnified lateral cross section of theaortic catheter 100 of FIG. 1 taken along line 2--2, the proximalportion 1 of the catheter shaft 102 has six lumens: a corporealperfusion lumen 108, an arch perfusion lumen 110, an arch pressure lumen112, a balloon inflation lumen 114, a guide wire and cardioplegia lumen116 and a root pressure lumen 118.

As shown in FIG. 3, which is a magnified lateral cross section of theaortic catheter 100 of FIG. 1 taken along line 3--3, five of the sixlumens continue into the distal portion 2 of the catheter shaft 102: thearch perfusion lumen 110, the arch pressure lumen 112, the ballooninflation lumen 114, the guide wire and cardioplegia lumen 116 and theroot pressure lumen 118. FIG. 4 is a distal view of the distal end 106taken along line 4-4 showing the root pressure port 134 and theguidewire/cardioplegia port 136.

The distal portion 2 of the catheter shaft 102 preferably has a lengthof approximately 30 to 60 cm, with the proximal portion 1 making up theremainder of the overall length of the elongated catheter shaft 102. Theelongated catheter shaft 102 has an outer diameter which is preferablyfrom approximately 9 to 22 French (3.0-7.3 mm diameter), more preferablyfrom approximately 12 to 18 French (4.0-6.0 mm diameter) for adult humanpatients. Catheters for pediatric patients may be somewhat smaller.Preferably, the elongated catheter shaft 102 is relatively constant indiameter along its length, as shown in FIG. 1. Alternatively, theproximal portion 1 may be made with an outer diameter somewhat largerthan the distal portion 2, with a smoothly tapered transition betweenthe two portions.

It should be noted that, for use in animal models, such as porcine orcanine models, the size of the aortic catheter 100 may vary somewhat,depending on the size of the animal subject. In exemplary embodimentsintended for use in a porcine model, the aortic catheter 100 was madewith a catheter shaft 102 having an outside diameter in one case of 10.5French (3.5 mm) and in another case of 12 French (4.0 mm) and an overalllength of 50-52 cm, a distal portion 2 of 30-34 cm and a proximalportion 1 of 16-22 cm. FIGS. 5 and 6 are full scale drawings of lateralcross sections taken along line 1--1 and line 2--2 in FIG. 1,respectively, showing the actual size of a catheter with a 10.5 French(3.5 mm) outer diameter. FIGS. 7 and 8 are full scale drawings oflateral cross sections taken along line 2--2 and line 3--3 in FIG. 1,respectively, showing the actual size of a catheter with a 12 French(4.0 mm) outer diameter.

The proximal portion 1 and the distal portion 2 of the elongatedcatheter shaft 102 are preferably formed of a flexible thermoplasticmaterial, a thermoplastic elastomer or a thermoset elastomer. Theproximal portion 1 and the distal portion 2 of the catheter shaft 102may be fabricated separately by known extrusion methods and joinedtogether end-to-end, for example by heat welding or by adhesive bonding.Alternatively, the proximal portion 1 and the distal portion 2 of thecatheter shaft 102 may be fabricated by dipping or by compositeconstruction techniques and joined together or the entire catheter shaft102 may be fabricated integrally. Suitable materials for the elongatedcatheter shaft 102 include, but are not limited to, polyvinylchloride,polyurethane, polyethylene, polypropylene, polyamides (nylons),polyesters, silicone, latex, and alloys or copolymers thereof, as wellas braided, coiled or counterwound wire or filament reinforcedcomposites.

An upstream occlusion member 120 is mounted on the distal portion 2 ofthe catheter shaft 102 near the distal end 106 of the catheter 100. Theupstream occlusion member 120 in this embodiment is in the form of anexpandable, inflatable balloon bonded to the catheter shaft 102 by heatwelding or with an adhesive. Suitable materials for the inflatableballoon upstream occlusion member 120 include flexible polymers andelastomers, which include, but are not limited to, polyvinylchloride,polyurethane, polyethylene, polypropylene, polyamides (nylons),polyesters, latex, silicone, and alloys, copolymers and reinforcedcomposites thereof. In addition, the outer surface of the upstreamocclusion member 120 may include a friction increasing coating ortexture to increase friction with the aortic wall when deployed. Theinflatable balloon upstream occlusion member 120 has a deflated state,in which the diameter of the occlusion member 120 is preferably not muchlarger than the diameter of the catheter shaft 102, and an inflatedstate, in which the occlusion member 120 expands to a diametersufficient to occlude blood flow in the ascending aorta of the patient.For use in adult human patients, the inflatable balloon upstreamocclusion member 120 preferably has an inflated outer diameter ofapproximately 1.5 cm to 5.0 cm. Preferably, the inflatable balloonupstream occlusion member 120 has an inflated length that is notsignificantly longer than its inflated diameter, or, more preferably, isshorter than its inflated diameter. This shortened inflated profileallows the upstream occlusion member 120 to be easily placed within theascending aorta between the coronary arteries and the brachiocephalicartery without any danger of inadvertently occluding either.

A downstream anchoring member 122 is mounted on the distal portion 2 ofthe catheter shaft 102 at a position proximal to and spaced apart fromthe upstream occlusion member 120. The distance between the upstreamocclusion member 120 and the downstream anchoring member 122 ispreferably between 3 and 20 cm, more preferably between 8 and 15 cm, andis chosen so that when the aortic catheter 100 is deployed and theupstream occlusion member 120 is positioned within the ascending aortabetween the coronary arteries and the brachiocephalic artery, thedownstream anchoring member 122 will be positioned in the descendingaorta downstream of the left subclavian artery. The downstream anchoringmember 122 in this embodiment is in the form of an expandable,inflatable balloon bonded to the catheter shaft 102 by heat welding orwith an adhesive. The downstream anchoring member 122 is preferablylarger, that is to say, more elongated, than the upstream occlusionmember 120. Suitable materials for the inflatable balloon downstreamanchoring member 122 include flexible polymers and elastomers, whichinclude, but are not limited to, polyvinylchloride, polyurethane,polyethylene, polypropylene, polyamides (nylons), polyesters, latex,silicone, and alloys, copolymers and reinforced composites thereof. Inaddition, the outer surface of the downstream anchoring member 122 mayinclude a friction increasing coating or texture to increase frictionwith the aortic wall when deployed.

The inflatable balloon downstream anchoring member 122 has a deflatedstate, in which the diameter of the anchoring member 122 is preferablynot much larger than the diameter of the catheter shaft 102, and aninflated state, in which the anchoring member 122 expands to a diametersufficient to occlude blood flow in the descending aorta of the patient.For use in adult human patients, the inflatable balloon downstreamanchoring member 122 preferably has an inflated outer diameter ofapproximately 1.5 cm to 5.0 cm and a length of approximately 3.5 cm to7.5 cm. The more elongated form of the inflatable balloon downstreamanchoring member 122 creates greater anchoring friction against the wallof the descending aorta when the downstream anchoring member 122 isinflated in order to prevent migration of the aortic catheter 100 due topressure gradients within the aorta during perfusion.

The corporeal perfusion lumen 108 extends through the proximal portion 1of the catheter shaft 102 from the proximal end 104 to one or morecorporeal perfusion ports 124 on the exterior of the catheter shaft 102proximal of the downstream anchoring member 122. The corporeal perfusionlumen 108 terminates and is sealed off proximal to the distal portion 2of the catheter shaft 102. This allows additional space for the archperfusion lumen 110 in the distal portion 2 of the catheter shaft 102for greater fluid flow to the aortic arch. The arch perfusion lumen 110extends through the catheter shaft 102 from the proximal end 104 to oneor more arch perfusion ports 126 on the exterior of the catheter shaft102 between the upstream occlusion member 120 and the downstreamanchoring member 122. Preferably, the arch perfusion lumen 110 makes asmoothly tapered transition where it increases in cross sectional areabetween the proximal portion 1 and the distal portion 2 of the cathetershaft 102 in order to minimize pumping head loss through the lumen. Thearch pressure lumen 110 extends through the catheter shaft 102 from theproximal end 104 to an arch pressure port 128 located between theupstream occlusion member 120 and the downstream anchoring member 122 tomonitor pressure in the aortic arch. The balloon inflation lumen 114extends through the catheter shaft 102 from the proximal end 104 toballoon inflation ports 130 and 132 within the upstream occlusion member120 and the downstream anchoring member 122, respectively. Thus, thecommon balloon inflation lumen 114 serves for simultaneous inflation anddeflation of both the upstream occlusion member 120 and the downstreamanchoring member 122. Alternatively, separate inflation lumens may beprovided for independently inflating the upstream occlusion member 120and the downstream anchoring member 122.

The root pressure lumen 118 extends through the catheter shaft 102 fromthe proximal end 104 to a root pressure port 134 near the distal end 106of the catheter shaft 102 to monitor pressure in the aortic root. Theguide wire and cardioplegia lumen 116 extends from the proximal end 104of the catheter shaft 102 to a guide wire/cardioplegia port 136 at thedistal end 106 of the catheter shaft 102, distal to the upstreamocclusion member 120. Preferably, the distal end 106 of the cathetershaft 102 is smoothly tapered or rounded for easy introduction and toavoid trauma or injury to the aortic wall during insertion or withdrawalof the aortic catheter 100. Preferably, the proximal end 104 of thecatheter shaft 102 and each of the lumens are connected to a manifoldand appropriate fittings, as will be discussed in more detail below.

Preferably, the aortic catheter 100 includes one or more markers, whichmay include radiopaque markers and/or sonoreflective markers, to enhanceimaging of the aortic catheter 100 using fluoroscopy or ultrasound, suchas transesophageal echocardiography (TEE). In this illustrativeembodiment, the aortic catheter 100 includes a distal radiopaque marker138 positioned near the distal end 106 of the catheter shaft 102, anintermediate radiopaque marker 140 positioned near the proximal edge ofthe upstream occlusion member 120, and a proximal radiopaque marker 142positioned near the distal edge of the downstream anchoring member 122.Each of the radiopaque markers 138, 140, 142 may be made of a ring ofdense radiopaque metal, such as gold, platinum, tantalum, tungsten oralloys thereof, or a ring of a polymer or adhesive material heavilyloaded with a radiopaquc filler material.

FIGS. 9 through 13 illustrate the shaft portion of a second embodimentof the aortic catheter 200, which is also configured for retrogradedeployment via a peripheral artery, such as the femoral artery. FIG. 9is a side view of the shaft portion of the aortic catheter 200. FIG. 10is a magnified lateral cross section of the aortic catheter 200 takenalong line 10--10 in FIG. 9. FIG. 11 is a magnified distal end view ofthe aortic catheter 200 taken along line 11--11 in FIG. 9. This secondembodiment of the aortic catheter 200 is very similar in materials,construction and dimensions to the first embodiment 100 previouslydescribed, with the exception that the corporeal perfusion lumen hasbeen eliminated. The aortic catheter 200 has an elongated catheter shaft202 having a proximal end 204 and a distal end 206. An upstreamocclusion member 220, in the form of an inflatable balloon, is mountedon the catheter shaft 202 near the distal end 206 of the catheter shaft202 so that it is positioned in the ascending aorta when deployed. Alarger, more elongated, inflatable balloon, which serves as a downstreamanchoring member 222, is mounted at a position proximal to the upstreamocclusion member 220 so that is positioned in the descending aorta whendeployed.

As shown in FIG. 10, which is a magnified lateral cross section of theaortic catheter of FIG. 9 taken along line 10--10, the catheter shaft202 has five lumens: an arch perfusion lumen 210, an arch pressure lumen212, a balloon inflation lumen 214, a guide wire and cardioplegia lumen216 and a root pressure lumen 218. The arch perfusion lumen 210 extendsthrough the catheter shaft 202 from the proximal end 204 to one or morearch perfusion ports 226 on the exterior of the catheter shaft 202between the upstream occlusion member 220 and the downstream anchoringmember 222. The arch pressure lumen 212 extends through the cathetershaft 202 from the proximal end 204 to an arch pressure port 228 locatedbetween the upstream occlusion member 220 and the downstream anchoringmember 222 to monitor pressure in the aortic arch. The balloon inflationlumen 214 extends through the catheter shaft 202 from the proximal end204 to balloon inflation ports 230 and 232 for simultaneous inflationand deflation of the upstream occlusion member 220 and the downstreamanchoring member 222. Alternatively, separate inflation lumens may beprovided for independently inflating the upstream occlusion member 220and the downstream anchoring member 222. The root pressure lumen 218extends through the catheter shaft 202 from the proximal end 204 to aroot pressure port 234 near the distal end 206 of the catheter shaft 202to monitor pressure in the aortic root. The guide wire and cardioplegialumen 216 extends from the proximal end 204 of the catheter shaft 202 toa guide wire/cardioplegia port 236 at the distal end 206 of the cathetershaft 202, distal to the upstream occlusion member 220.

The aortic catheter 200 includes a distal radiopaque marker 238positioned near the distal end 206 of the catheter shaft 202, anintermediate radiopaque marker 240 positioned near the proximal edge ofthe upstream occlusion member 220, and a proximal radiopaque marker 242positioned near the distal edge of the downstream anchoring member 222.The proximal end 204 of the catheter shaft 202 and each of the lumens isconnected to a manifold and appropriate fittings, as will be discussedin more detail below.

Preferably, the elongated catheter shaft 202 has an outer diameter whichis from approximately 9 to 22 French (3.0-7.3 mm diameter), morepreferably from approximately 12 to 18 French (4.0-6.0 mm diameter), andan overall length from approximately 60 to 120 cm, more preferably 70 to90 cm, for femoral artery deployment in adult human patients. Inexemplary embodiments intended for use in a porcine model, the aorticcatheter 200 was made with a catheter shaft 202 having an outsidediameter in one case of 10.5 French (3.5 mm) and in 10 another case of12 French (4.0 mm) and an overall length of 50-52 cm. FIG. 12 is a fullscale drawing of the lateral cross section taken along line 10--10 inFIG. 9 showing the actual size of a catheter 200 with a 10.5 French (3.5mm) outer diameter. FIG. 13 is a full scale drawing of the lateral crosssection taken along line 10--10 in FIG. 9 showing the actual size of acatheter 200 with a 12 French (4.0 mm) outer diameter.

This second embodiment of the aortic catheter 200 has a number ofpractical advantages over the first embodiment previously described. Theaortic catheter 200 is easier to construct, since the entire length ofthe catheter shaft 202 can be made of a single piece of extruded tubing.In addition, eliminating the corporeal perfusion lumen from the cathetershaft 202 creates more space for the arch perfusion lumen 212, allowinggreater arch perfusion flow for a given diameter of catheter shaft 202.The disadvantage of this variation is that the aortic catheter 200 doesnot provide any lumen for corporeal perfusion flow. Therefore, aseparate contralateral or coaxial arterial cannula would be used withthis embodiment of the aortic catheter 200 to supply oxygenated blood tothe corporeal circulation.

FIG. 14 shows a side view of an aortic catheter 100 according to thepresent invention with a catheter shaft 102 configured for retrogradedeployment via femoral artery access. The features shown in FIG. 14 areapplicable to the first or second embodiment of the aortic catheterpreviously described, as well as other aortic catheters described hereinthat are intended for retrograde deployment via femoral artery access.In order to facilitate placement of the aortic catheter 100 and toimprove the stability of the catheter 100 in the proper position in thepatient's aorta, a distal region 144 of the catheter shaft 102 may bepreshaped with a curve to match the internal curvature of the patient'saortic arch. The curved distal region 144 represents a J-shaped curve ofapproximately 180 degrees of arc with a radius of curvature ofapproximately 2 to 4 cm to match the typical curvature of the aorticarch in an adult human patient. In addition, the distal end 106 of thecatheter may be skewed slightly up out of the plane of the curve toaccommodate the forward angulation of the patient's ascending aorta.Additionally, the catheter shaft 102 may be reinforced, particularly inthe curved distal region 144, for example with braided or coiled wire,to further improve the stability of the catheter 100 in the properposition in the patient's aorta.

As mentioned above, the proximal end 104 of the catheter shaft 102 isconnected to a manifold 150 with fittings for each of the catheterlumens. The corporeal perfusion lumen 108 is connected to a Y-fitting162 that has a barb connector 152 for connection to a perfusion pump orthe like and a luer connector 154, which may be used for monitoringperfusion pressure, for withdrawing fluid samples or for injectingmedications or other fluids. Likewise, the arch perfusion lumen 110 isconnected to a Y-fitting 164 that has a barb connector 156 forconnection to a perfusion pump and a luer connector 158. The archpressure lumen 112 is connected to a luer connector 160 or other fittingsuitable for connection to a pressure monitor. The balloon inflationlumen 114 is connected to a luer connector 166 or other fitting,suitable for connection to a syringe or balloon inflation device. Theguide wire and cardioplegia lumen 116 is connected to a three-wayY-fitting 170 that has a barb connector 172 for connection to acardioplegia infusion pump, a luer connector 174 and a guide wire port176 with a Touhy-Borst adapter or other hemostasis valve. The rootpressure lumen 118 is connected to a luer connector 168 or otherfitting, suitable for connection to a pressure monitor. Naturally, theY-fitting 162 for the corporeal perfusion lumen 108 would be unnecessaryfor the second embodiment of the aortic catheter 200 described above.

FIG. 15 is a schematic diagram showing an aortic catheter 100 accordingto the present invention deployed within a patient's aorta via femoralartery access. The aortic catheter 100 is introduced into the patient'scirculatory system through a peripheral artery access, such as thefemoral artery, by the percutaneous Seldinger technique, through anintroducer sheath or via an arterial cutdown. In the case of the secondembodiment of the aortic catheter 100 described above, the catheter 100may optionally be introduced into the femoral artery through a coaxialarterial perfusion cannula (not shown). Meanwhile, one or more venouscannulas are introduced into the vena cava via the femoral vein or thejugular vein. The aortic catheter 100 is advanced up the descendingaorta and across the aortic arch under fluoroscopic or ultrasoundguidance with the aid of a guide wire within the guide wire andcardioplegia lumen 116. The aortic catheter 100 is advanced until theupstream occlusion member 120 is positioned within the ascending aortabetween the coronary arteries and the brachiocephalic artery and thedownstream anchoring member 122 is positioned in the descending aortadownstream of the left subclavian artery, as evidenced by the radiopaquemarkers 138, 140, 142, and the guide wire is withdrawn. Using amultihead cardiopulmonary bypass pump or the like, perfusion ofoxygenated blood is started through the corporeal perfusion ports 124(or arterial cannula) and the arch perfusion ports 126 to take some ofthe pumping load off of the heart. The upstream occlusion member 120 andthe downstream anchoring member 122 are then inflated, preferably withsaline solution or a mixture of saline and a radiopaque contrast agent,to partition the aorta, whereupon a cardioplegic agent, such coldcrystalloid cardioplegia or blood cardioplegia, is infused through theguide wire and cardioplegia lumen 116 to induce cardioplegic arrest.Perfusion is maintained through the corporeal perfusion ports 124 orarterial cannula and the arch perfusion ports 126 and cardioplegicarrest is maintained by continued infusion of the cardioplegic agentthrough the guide wire and cardioplegia lumen 116 or via retrogradeinfusion through a coronary sinus catheter as long as necessary forcompletion of the surgical procedure using minimally invasive orstandard open-chest techniques. Perfusion temperatures, perfusatecompositions and flow rates may be optimized to each of the segmentedregions of the patient's circulation for optimal organ preservationwhile on cardiopulmonary bypass. While the aortic catheter 100 isdeployed, the downstream anchoring member 122 stabilizes and anchors thecatheter shaft 102 and prevents upstream or downstream migration of thecatheter 100 or the upstream occlusion member 120 due to differentialpressures within the aorta. At the completion of the surgical procedure,the upstream occlusion member 120 and the downstream anchoring member122 are deflated to allow oxygenated blood to flow into the patient'scoronary arteries, whereupon the heart should spontaneously resumenormal sinus rhythm. If necessary, cardioversion or defibrillationshocks may be applied to restart the heart. The patient is then weanedoff of bypass and the aortic catheter 100 and any other cannulas arewithdrawn.

FIGS. 16 through 24 illustrate a third embodiment of the aortic catheter300 of the present invention, which is configured for antegradedeployment via an aortotomy or direct aortic puncture. FIG. 16 is a sideview of the shaft portion of the aortic catheter 300. FIG. 17 is amagnified lateral cross section of the aortic catheter 300 taken alongline 17--17 in FIG. 16. FIG. 18 is a magnified lateral cross section ofthe aortic catheter 300 taken along line 18--18 in FIG. 16. FIG. 19 is amagnified lateral cross section of the aortic catheter 300 taken alongline 19--19 in FIG. 16. In many respects this third embodiment of theaortic catheter 300 is similar in materials, construction and dimensionsto the first 100 and second 200 embodiments previously described,however because this catheter 300 is configured for antegradedeployment, the proximal and distal positions of many of the features ofthe catheter are reversed with respect to the retrograde embodimentspreviously described.

The aortic catheter 300 has an elongated catheter shaft 302 having aproximal end 304 and a distal end 306. Because the aortic catheter 300is introduced directly into the ascending aorta, the elongated cathetershaft 302 has an overall length of approximately 20 to 60 cm. Theelongated catheter shaft 302 has a proximal portion 1, an intermediateportion 2 and a distal portion 3, which are joined together end-to-end,as shown in FIG. 16. As shown in FIG. 17, which is a magnified lateralcross section of the aortic catheter 300 of FIG. 16 taken along line17--17, the proximal portion 1 of the catheter shaft 302 has fourlumens: a guide wire and corporeal perfusion lumen 308, an archperfusion lumen 310, an arch pressure lumen 312, a balloon inflationlumen 314. As shown in FIG. 18, which is a magnified lateral crosssection of the aortic catheter 300 of FIG. 16 taken along line 18--18,two of the four lumens continue into the intermediate portion 2 of thecatheter shaft 302: the balloon inflation lumen 314 and the guide wireand corporeal perfusion lumen 308. As shown in FIG. 19, which is amagnified lateral cross section of the aortic catheter 300 of FIG. 16taken along line 19--19, only the guide wire and corporeal perfusionlumen 308 continue into the distal portion 3 of the catheter shaft 302.The distal portion 3 of the catheter shaft 302 preferably has a lengthof approximately 2 to 10 cm, the intermediate portion 2 has a length ofapproximately 2 to 10 cm, with the proximal portion 1 making up theremainder of the overall length of the elongated catheter shaft 302. Theelongated catheter shaft 302 has an outer diameter which is preferablyfrom approximately 9 to 22 French (3.0-7.3 mm diameter), more preferablyfrom approximately 12 to 18 French (4.0-6.0 mm diameter) for adult humanpatients. Catheters for pediatric patients may be somewhat smaller.Preferably, the elongated catheter shaft 302 is relatively constant indiameter along its length, as shown in FIG. 16. Alternatively, thecatheter shaft 302 may taper at the transitions between the proximalportion 1, the intermediate portion 2 and the distal portion 3.

In exemplary embodiments intended for use in a porcine model, the aorticcatheter 300 was made with a catheter shaft 302 having an outsidediameter in one case of 10.5 French (3.5 mm) and in another case of 12French (4.0 mm) and an overall length of 25-28 cm. FIGS. 20 and 21 arefull scale drawings of lateral cross sections taken along line 17--17and line 18--18 in FIG. 16, respectively, showing the actual size of anaortic catheter 300 with a 10.5 French (3.5 mm) outer diameter. FIGS. 22and 23 are full scale drawings of lateral cross sections taken alongline 1--1 and line 2--2 in FIG. 16, respectively, showing the actualsize of an aortic catheter 300 with a 12 French (4.0 mm) outer diameter.

A downstream anchoring member 322, in the form of a large, i.e.elongated, expandable, inflatable balloon, is mounted on the cathetershaft 302 near the distal end 306 of the catheter shaft 302. Wheninflated, the downstream anchoring member 322 expands to a diametersufficient to occlude blood flow in the descending aorta. For use inadult human patients, the inflatable balloon downstream anchoring member322 preferably has an inflated outer diameter of approximately 1.5 cm to4.0 cm and a length of approximately 3.5 cm to 7.5 cm. An upstreamocclusion member 320, in the form of an expandable, inflatable balloon,is mounted on the catheter shaft 302 at a position proximal to andspaced apart from the downstream anchoring member 322 so that it ispositioned in the ascending aorta when deployed. The distance betweenthe upstream occlusion member 320 and the downstream anchoring member322 is preferably between 3 and 20 cm, more preferably between 8 and 15cm, and is chosen so that, when the aortic catheter 300 is deployed andthe upstream occlusion member 320 is positioned within the ascendingaorta between the coronary arteries and the brachiocephalic artery, thedownstream anchoring member 322 will be positioned in the descendingaorta downstream of the left subclavian artery. When inflated, theupstream occlusion member 320 expands to a diameter sufficient toocclude blood flow in the ascending aorta. For use in adult humanpatients, the inflatable balloon upstream occlusion member 320preferably has an inflated outer diameter of approximately 1.5 cm to 4.0cm. Preferably, the inflatable balloon upstream occlusion member 320 hasan inflated length that is not significantly longer than its inflateddiameter, or, more preferably, is shorter than its inflated diameter toallows the upstream occlusion member 320 to be easily placed within theascending aorta between the coronary arteries and the brachiocephalicartery without any danger of inadvertently occluding either.

The arch perfusion lumen 310 extends through the catheter shaft 302 fromthe proximal end 304 to one or more arch perfusion ports 326 on theexterior of the catheter shaft 302 between the upstream occlusion member320 and the downstream anchoring member 322. The arch pressure lumen 312extends through the catheter shaft 302 from the proximal end to an archpressure port 328 located between the upstream occlusion member 320 andthe downstream anchoring member 322 to monitor pressure in the aorticarch. The common balloon inflation lumen 314 extends through thecatheter shaft 302 from the proximal end 304 to balloon inflation ports330, 332 within the upstream occlusion member 320 and the downstreamanchoring member 322, respectively. Alternatively, separate inflationlumens may be provided for independently inflating the upstreamocclusion member 320 and the downstream anchoring member 322. The guidewire and corporeal perfusion lumen 308 extends from the proximal end 304of the catheter shaft 302 to one or more corporeal perfusion ports 324and a guide wire port 336 at the distal end 306, distal to thedownstream anchoring member 322. The aortic catheter 300 includes adistal radiopaque marker 338 positioned near the distal end 306 of thecatheter shaft 302, an intermediate radiopaque marker 340 positionednear the proximal edge of the downstream anchoring member 322, and aproximal radiopaque marker 342 positioned near the distal edge of theupstream occlusion member 320. As this embodiment of the aortic catheter300 does not include a cardioplegia lumen, a separate cardioplegianeedle or catheter would be used with this embodiment to infusecardioplegia fluid into the aortic root upstream of the upstreamocclusion member 320. Alternatively, a cardioplegia lumen with one ormore cardioplegia ports could be included in the proximal portion 1 ofthe catheter shaft 302.

FIG. 24 shows a side view of an aortic catheter 300 according to thepresent invention with a catheter shaft 302 configured for antegradedeployment via central access through an aortotomy or direct puncture inthe ascending aorta. The features shown in FIG. 24 are applicable to thethird embodiment of the aortic catheter previously described, as well asother aortic catheters described herein that are intended for antegradedeployment. In order to facilitate placement of the aortic catheter 300and to improve the stability of the catheter 300 in the proper positionin the patient's aorta, a distal region 344 of the catheter shaft 302may be preshaped with a curve to match the internal curvature of thepatient's aortic arch. The curved distal region 344 represents anS-shaped curve with a primary curve 346 of approximately 180 degrees ofarc with a radius of curvature of approximately 2 to 4 cm to match thetypical curvature of the aortic arch in an adult human patient and asecondary curve 348 that is a bend of approximately 90 degrees or morewhere the catheter shaft 302 will pass through the aortic wall.Additionally, the catheter shaft 302 may be reinforced, particularly inthe curved distal region 344, for example with braided or coiled wire,to further improve the stability of the catheter 300 in the properposition in the patient's aorta.

The proximal end 304 of the catheter shaft 302 is connected to amanifold 350 with fittings for each of the catheter lumens. The archperfusion lumen 310 is connected to a Y-fitting 364 that has a barbconnector 356 for connection to a perfusion pump or the like and a luerconnector 358, which may be used for monitoring perfusion pressure, forwithdrawing fluid samples or for injecting medications or other fluids.

The arch pressure lumen 312 is connected to a luer connector 360 orother fitting suitable for connection to a pressure monitor. The ballooninflation lumen 314 is connected to a luer connector 366 or otherfitting suitable for connection to a syringe or balloon inflationdevice. The guide wire and corporeal perfusion lumen 308 is connected toa three-way Y-fitting 370 that has a barb connector 372 for connectionto a perfusion pump, a luer connector 374 and a guide wire port 376 witha Touhy-Borst adapter or other hemostasis valve. An additional Y-fittingwould be necessary if a cardioplegia lumen were included in the aorticcatheter 300.

FIG. 25 is a schematic diagram showing an aortic catheter 300 accordingto the present invention deployed within a patient's aorta via anaortotomy incision in the ascending aorta.

First, the patient's ascending aorta is accessed through a stemotomy, athoracotomy or using a port-access approach. A purse string suture isplaced in the wall of the ascending aorta and an aortotomy incision ismade inside of the purse string. Then, the aortic catheter 300 isintroduced into the patient's ascending aorta through the aortotomyincision. Meanwhile, one or more venous cannulas are introduced into thevena cava via the femoral vein or the jugular vein. The aortic catheter300 is advanced up the ascending aorta and across the aortic arch underfluoroscopic or ultrasound guidance, or under direct visualization withthe aid of a guide wire within the guide wire and corporeal perfusionlumen 308. The aortic catheter 300 is advanced until the upstreamocclusion member 320 is positioned within the ascending aorta betweenthe coronary arteries and the brachiocephalic artery and the downstreamanchoring member 322 is positioned in the descending aorta downstream ofthe left subclavian artery, as evidenced by the radiopaque markers 338,340, 342, and the guide wire is withdrawn. Using a multiheadcardiopulmonary bypass pump or the like, perfusion of oxygenated bloodis started through the corporeal perfusion ports 324 and the archperfusion ports 326 to take some of the pumping load off of the heart.The upstream occlusion member 320 and the downstream anchoring member322 are then inflated to partition the aorta, whereupon a cardioplegicagent, such cold crystalloid cardioplegia or blood cardioplegia, isinfused through a separate cardioplegia needle or catheter placed in theaortic root upstream of the upstream occlusion member 320 (or throughthe optional cardioplegia lumen) to induce cardioplegic arrest.Perfusion is maintained through the corporeal perfusion ports 324 andthe arch perfusion ports 326 and cardioplegic arrest is maintained bycontinued infusion of the cardioplegic agent through the cardioplegianeedle or catheter or via retrograde infusion through a coronary sinuscatheter as long as necessary for completion of the surgical procedureusing minimally invasive or standard open-chest techniques. Perfusiontemperatures, perfusate compositions and flow rates may be optimized toeach of the segmented regions of the patient's circulation for optimalorgan preservation while on cardiopulmonary bypass. While the aorticcatheter 300 is deployed, the downstream anchoring member 322 stabilizesand anchors the catheter shaft 302 and prevents upstream or downstreammigration of the catheter 300 or the upstream occlusion member 320 dueto differential pressures within the aorta. At the completion of thesurgical procedure, the upstream occlusion member 320 and the downstreamanchoring member 322 are deflated to allow oxygenated blood to flow intothe patient's coronary arteries, whereupon the heart shouldspontaneously resume normal sinus rhythm. If necessary, cardioversion ordefibrillation shocks may be applied to restart the heart. The patientis then weaned off of bypass and the aortic catheter 300 and any othercannulas are withdrawn.

FIGS. 26 through 30 show several alternate embodiments of the aorticcatheter of the present invention illustrating some of the variationspossible for the upstream occlusion member and the downstream anchoringmember. These variations are equally applicable to catheters configuredfor retrograde deployment via peripheral artery access or for antegradedeployment via an aortotomy incision in the ascending aorta. The exactconfigurations of the embodiments shown are illustrative of only a fewof the many possible variations of the aortic catheter of the presentinvention and therefore should not be considered as limiting examples.

FIG. 26 is a schematic diagram showing a fourth embodiment of the aorticcatheter 400 of the present invention deployed within a patient's aortavia femoral artery access. In many respects this fourth embodiment ofthe aortic catheter 400 is similar in materials, construction anddimensions to the first 100 and second 200 embodiments previouslydescribed, with the exception that the upstream occlusion member 420 isin the form of a narrow, disk-shaped balloon. In this embodiment, thenarrow, disk-shaped balloon upstream occlusion member 420 is formed withan outer toroidal section 422 joined to the catheter shaft 402 by a web426. One or more spoke-like radial inflation passages 424 connect theinflation port or ports 430 on the catheter shaft 402 with the outertoroidal section 422. When inflated, the outer toroidal section 422 ofthe upstream occlusion member 420 expands to a diameter sufficient toocclude blood flow in the ascending aorta. For use in adult humanpatients, the upstream occlusion member 420 preferably has an inflatedouter diameter of approximately 1.5 to 4.0 cm. One manner of fabricatingthe upstream occlusion member 420 is by making a roughly spherical ordisk-shaped balloon preform by known balloon forming techniques, thenjoining sectors of the proximal and distal surface of the balloonpreform to one another by heat welding or adhesive bonding to form a web426, leaving open radial inflation passages 424 connected to the outertoroidal section 422. Other suitable processes for fabricating theupstream occlusion member 420 include dip molding the upstream occlusionmember 420 on a positive mold using a lost wax process and slurrymolding or rotational molding the upstream occlusion member 420 in anegative mold. Suitable materials for the inflatable balloon upstreamocclusion member 420 include flexible polymers and elastomers, whichinclude, but are not limited to, polyvinylchloride, polyurethane,polyethylene, polypropylene, polyamides (nylons), polyesters, latex,silicone, and alloys, copolymers and reinforced composites thereof. Inaddition, the outer surface of the upstream occlusion member 420 mayinclude a friction increasing coating or texture to increase frictionwith the aortic wall when deployed. The narrow, disk-shaped profile ofthe upstream occlusion member 420 allows it to be easily placed withinthe ascending aorta between the coronary arteries and thebrachiocephalic artery without any danger of inadvertently occludingeither. As noted above, this embodiment may also be configured forantegrade deployment via an aortotomy incision in the ascending aorta,similar to the third embodiment 300 previously described.

FIG. 27 is a schematic diagram showing a fifth embodiment of the aorticcatheter 500 of the present invention deployed within a patient's aortavia an aortotomy incision in the ascending aorta. In many respects thisfifth embodiment of the aortic catheter 500 is similar in materials,construction and dimensions to the third 300 embodiment previouslydescribed, with the exception that the upstream occlusion member 520 isin the form of a narrow, disk-shaped balloon. In this embodiment, thenarrow, disk-shaped balloon upstream occlusion member 520 has anupstream surface 522 and a downstream surface 534 that are joined to oneanother at a multiplicity of adhesion points 526 in a quilt-likepattern.

The adhesion points 526 may be formed by heat welding or adhesivebonding or the occlusion member 520 may have an internal structure suchas fibers or other connecting members joining the upstream surface 522to the downstream surface 534. The quilt-like pattern of adhesion points526 allows the occlusion member 520 to maintain its narrow, disk-shapedprofile when inflated. When inflated, the upstream occlusion member 520expands to a diameter sufficient to occlude blood flow in the ascendingaorta, preferably between approximately 1.5 and 4.0 cm. Suitablematerials for the inflatable balloon upstream occlusion member 520include flexible polymers and elastomers, which include, but are notlimited to, polyvinylchloride, polyurethane, polyethylene,polypropylene, polyamides (nylons), polyesters, latex, silicone, andalloys, copolymers and reinforced composites thereof. In addition, theouter surface of the upstream occlusion member 520 may include afriction increasing coating or texture to increase friction with theaortic wall when deployed. The narrow, disk-shaped profile of theupstream occlusion member 520 allows it to be easily placed within theascending aorta between the coronary arteries and the brachiocephalicartery without any danger of inadvertently occluding either. As notedabove, this embodiment may also be configured for retrograde deploymentvia peripheral artery access, similar to the first 100 or second 200embodiments previously described.

FIG. 28 is a schematic diagram showing a sixth embodiment of the aorticcatheter 600, having an upstream occlusion member 620 in the form of aselectively deployable peripheral flow external catheter valve, deployedwithin a patient's aorta via femoral artery access. As noted above, thisembodiment may also be configured for antegrade deployment via anaortotomy incision in the ascending aorta. In this exemplary embodiment,the upstream occlusion member 620 would preferably be in the form of anantegrade, peripheral flow valve, as described in commonly owned, patentapplication Ser. No. 08/665,635, and co owned U.S. Pat. Nos., 5,827,237and 5,833,671, which have previously been incorporated by reference. Theperipheral flow valve upstream occlusion member 620 is constructed withone or more valve leaflets 622 pivotally attached to the catheter shaft602. The leaflets 622 of the peripheral flow valve 620 tend to pivotoutward to seal against the wall of the ascending aorta in response topositive perfusion pressure in the aortic arch downstream of theocclusion member 620. Alternatively or in addition to this passive valveaction, the peripheral flow valve upstream occlusion member 620 may beactively deployed by one or more actuation wires (not shown) extendingthrough the elongated catheter shaft 602 and attached to the valveleaflets 622.

FIG. 29 is a schematic diagram showing a seventh embodiment of theaortic catheter 700, having an upstream occlusion member 720 in the formof a selectively deployable central flow external catheter valvedeployed within a patient's aorta via femoral artery access. As notedabove, this embodiment may also be configured for antegrade deploymentvia an aortotomy incision in the ascending aorta. In this exemplaryembodiment, the upstream occlusion member 720 would preferably be in theform of an antegrade, central flow valve, as described in in commonlyowned, patent application Ser. No. 08/665,635, and co owned U.S. Pat.No., 5,827,237 and 5,833,671, which have previously been incorporated byreference. The central flow valve upstream occlusion member 720 isconstructed with a selectively expandable skeleton structure 722 that ismounted on the catheter shaft 702. In one preferred embodiment, theskeleton structure 722 has an inflatable outer rim 724 supported on thecatheter shaft 702 by a plurality of inflatable radial spokes 726.Between the inflatable outer rim 724 and radial spokes 726 are aplurality of flow fenestrations 728. One or more valve leaflets 730(shown in the open position for clarity) are pivotally attached to theouter rim 724 or the radial spokes 726 of the skeleton structure 722.The leaflets 730 of the central flow valve tend to pivot inward to sealthe flow fenestrations 728 in response to positive perfusion pressure inthe aortic arch downstream of the occlusion member 720. Alternatively orin addition to this passive valve action, the central flow valveupstream occlusion member 720 may be actively deployed by one or moreactuation wires (not shown) extending through the elongated cathetershaft 702 and attached to the valve leaflets 730.

FIG. 30 is a schematic diagram showing an eighth embodiment of theaortic catheter 800, having a downstream anchoring member 820 in theform of two inflatable balloons 822, 824, deployed within a patient'saorta via femoral artery access. In many respects this eighth embodimentof the aortic catheter 800 is similar in materials, construction anddimensions to the first 100 and second 200 embodiments previouslydescribed, with the exception that the downstream anchoring member 820is constructed in the form of two or more inflatable balloons 822, 824as another means to achieve the elongated geometry of the downstreamanchoring member in the embodiments previously described. Each of theinflatable balloons 822, 824 is approximately spherical in profile withan inflated diameter sufficient to occlude blood flow in the descendingaorta, preferably between approximately 1.5 and 4.0 cm. Suitablematerials for the inflatable balloons 822, 824 of the downstreamanchoring member 820 include flexible polymers and elastomers, whichinclude, but are not limited to, polyvinylchloride, polyurethane,polyethylene, polypropylene, polyamides (nylons), polyesters, latex,silicone, and alloys, copolymers and reinforced composites thereof. Inaddition, the outer surface of the inflatable balloons 822, 824 mayinclude a friction increasing coating or texture to increase frictionwith the aortic wall when deployed. Using a plurality of inflatableballoons 822, 824 in the downstream anchoring member 820 has theadvantages of greater inflation strength, greater dimensional stabilityand greater resistance to axial movement of the catheter shaft 802 withrespect to the downstream anchoring member 820 when deployed. As notedabove, this embodiment may also be configured for antegrade deploymentvia an aortotomy incision in the ascending aorta, similar to the thirdembodiment 300 previously described.

What is claimed is:
 1. An aortic catheter comprising:an elongatedcatheter shaft configured for introduction into a patient's aorta andhaving a proximal end and a distal end; an upstream occlusion memberhaving an expanded diameter sufficient to block blood flow through theaorta; and a downstream anchoring member sized and configured to have alength greater than its diameter and adapted to stabilize the positionof the aortic catheter within the aorta.
 2. The aortic catheter of claim1, wherein said upstream occlusion member and said downstream anchoringmember are positioned on said elongated catheter shaft such that, whensaid elongated catheter shaft is introduced into the patient's aorta,said upstream occlusion member is positioned in the ascending aortabetween the coronary arteries and the brachiocephalic artery and saiddownstream anchoring member is positioned in the descending aorta,downstream of the aortic arch.
 3. The aortic catheter of claim 2,further comprising an arch perfusion lumen extending through saidelongated catheter shaft from said proximal end to at least one archperfusion port on said elongated catheter shaft between said upstreamocclusion member and said downstream anchoring member.
 4. The aorticcatheter of claim 3, further comprising an arch pressure lumen extendingthrough said elongated catheter shaft from said proximal end to an archpressure port on said elongated catheter shaft between said upstreamocclusion member and said downstream anchoring member.
 5. The aorticcatheter of claim 2, further comprising a corporeal perfusion lumenextending through said elongated catheter shaft from said proximal endto at least one corporeal perfusion port on said elongated cathetershaft downstream of said upstream occlusion member and said downstreamanchoring member.
 6. The aortic catheter of claim 2, further comprisinga cardioplegia lumen extending through said elongated catheter shaftfrom said proximal end to at least one cardioplegia port on saidelongated catheter shaft upstream of said upstream occlusion member andsaid downstream anchoring member.
 7. The aortic catheter of claim 6,further comprising a root pressure lumen extending through saidelongated catheter shaft from said proximal end to a root pressure porton said elongated catheter shaft upstream of said upstream occlusionmember and said downstream anchoring member.
 8. The aortic catheter ofclaim 1, wherein said upstream occlusion member is an expandable,inflatable balloon.
 9. The aortic catheter of claim 8, furthercomprising a balloon inflation lumen extending through said elongatedcatheter shaft from said proximal end to a balloon inflation port onsaid elongated catheter shaft within said expandable, inflatableballoon.
 10. The aortic catheter of claim 1, wherein said upstreamocclusion member is a narrow disk-shaped inflatable balloon.
 11. Theaortic catheter of claim 1, wherein said upstream occlusion member is aperipheral flow external catheter valve.
 12. The aortic catheter ofclaim 1, wherein said upstream occlusion member is a central flowexternal catheter valve.
 13. The aortic catheter of claim 1, whereinsaid downstream anchoring member is an elongated, expandable, inflatableballoon.
 14. The aortic catheter of claim 13, further comprising aballoon inflation lumen extending through said elongated catheter shaftfrom said proximal end to a balloon inflation port on said elongatedcatheter shaft within said elongated, expandable, inflatable balloon.15. The aortic catheter of claim 1, wherein said downstream anchoringmember comprises a plurality of inflatable balloons.
 16. The aorticcatheter of claim 1, wherein said elongated catheter shaft is configuredfor introduction into the patient's aorta via a peripheral arteryaccess.
 17. The aortic catheter of claim 1, wherein said elongatedcatheter shaft is configured for introduction into the patient's aortavia femoral artery access.
 18. The aortic catheter of claim 17, whereinsaid elongated catheter shaft has a distal region with a curveconfigured to match an internal curvature of the patient's aortic arch.19. The aortic catheter of claim 1, wherein said elongated cathetershaft is configured for introduction into the patient's aorta via anaortotomy incision in the ascending aorta.
 20. The aortic catheter ofclaim 19, wherein said elongated catheter shaft has a distal region witha curve configured to match an internal curvature of the patient'saortic arch.
 21. The aortic catheter of claim 1, wherein said upstreamocclusion member is a first inflatable balloon having a first length;and said downstream anchoring member is a second inflatable balloonhaving a second length, wherein said second length is greater than saidfirst length.
 22. The aortic catheter of claim 21, wherein said firstlength is less than said expanded diameter of said upstream occlusionmember.
 23. A method comprising:introducing an aortic catheter into apatient's aorta, the aortic catheter having an elongated catheter shaftwith a proximal end and a distal end, an upstream occlusion member and adownstream anchoring member, said downstream anchoring member sized andconfigured to have a length greater than its diameter and adapted tostabilize the position of the aortic catheter in a patient's aorta;expanding said upstream occlusion member in the ascending aorta betweenthe coronary arteries and the brachiocephalic artery and expanding saiddownstream anchoring member in the descending aorta, downstream of theaortic arch; and perfusing the patient's aortic arch with fluid throughan arch perfusion lumen extending through said elongated catheter shaftfrom said proximal end to at least one arch perfusion port on saidelongated catheter shaft between said upstream occlusion member and saiddownstream anchoring member.
 24. The method of claim 23, furthercomprising perfusing the patient's descending aorta with fluid through acorporeal perfusion lumen extending through said elongated cathetershaft from said proximal end to at least one corporeal perfusion port onsaid elongated catheter shaft downstream of said upstream occlusionmember and said downstream anchoring member.
 25. The method of claim 23,further comprising inducing cardioplegic arrest by infusing acardioplegic agent through a cardioplegia lumen extending through saidelongated catheter shaft from said proximal end to at least onecardioplegia port on said elongated catheter shaft upstream of saidupstream occlusion member and said downstream anchoring member.